Every Expression Host. Every Therapeutic Format. One CDMO.
Elise Biopharma unifies the full spectrum of biologics manufacturing—microbial, yeast, mammalian, insect, plant, and cell-free—under a single, harmonized quality system. From single-domain nanobodies and complex fusion proteins to LNP-mRNA, viral vectors, vaccines, enzymes, exosomes, and live biotherapeutics, our platforms are industrialized, phase-appropriate, and designed for clean tech transfer from IND through BLA and commercial supply.
What differentiates us isn’t just breadth—it’s coherence. Common analytics, shared digital QMS, and aligned CMC playbooks mean your molecule moves between hosts and formats without losing time or truth. PAT-enabled upstream, smart downstream design spaces, and right-sized formulation strategies turn development into a repeatable system rather than a one-off sprint.
Below is a concise tour of each modality we run at late-clinical or commercial scale. Explore any heading to see capabilities, equipment, case studies, release specs, and typical timelines—then stitch the pieces into a single, end-to-end path that fits your program.
Microbial CDMO Services
Our modular E. coli and Pichia pastoris platforms combine CRISPR-engineered strains, AI-driven fed-batch control, and 5 L ➝ 2 000 L stainless-and-single-use fermentors. We routinely hit 8–12 g L⁻¹ soluble protein with <0.05 EU mg⁻¹ endotoxin after a two-step chromatography train. Typical outputs include therapeutic enzymes (ERT), vaccine antigens, VLPs, and catalyst-grade industrial proteins. Rapid tech-transfer packages let you jump straight from lab notebook to IND-ready batch in as little as 8 months.
mRNA CDMO Services
Elise’s mRNA suite features clinical-grade plasmid supply, linearized-template IVT up to 30 g per run, proprietary cap-analog chemistries (CleanCap®, TriLink-compatible), and lipid-nanoparticle (LNP) formulation lines rated to <80 nm PDI 0.05. In-line digital PAT tracks NTP consumption, Mg²⁺ kinetics, and capping efficiency for every lot. Integrated sterility, dsRNA quant, and potency assays support both vaccine and gene-editing payloads, while our BSL-2 fill-finish isolators handle vial or PFS formats at –20 °C or LN₂ logistics temperatures.
Antibody Fragments & Nanobodies
Single-domain VHHs, diabodies, minibodies, scFv-fusions—our fragment platform leverages microbial or mammalian hosts depending on folding complexity. Phage/yeast display libraries jump-start affinity maturation, while periplasmic expression and refolding workflows maximize solubility. Typical deliverables include 95 % monomeric purity, endotoxin <0.1 EU mg⁻¹, and kilogram-scale GMP supply for inhaled, topical, or systemic routes. Humanization, developability profiling, and viscosity modeling come standard.
Recombinant Proteins & Enzymes
Whether you need a 150 mg feasibility lot for in-vivo proof-of-concept or a 12 kg commercial campaign, our recombinant protein line delivers. Capabilities include periplasmic scFv expression, glyco-optimized Pichia cytokines, and multistep enzyme purification to ≥99 % UV280 purity. Automated TFF skids, multi-column chromatography (SMB, PCC), and SEC-MALS analytics lock in consistency across scales, while ISO 13485 registration covers diagnostic-grade enzyme production for IVD OEM partners.
Fc-Fusion & Bispecifics
From albumin-fusion half-life extenders to dual-variable-domain antibodies and CD3-engaging BiTEs, Elise provides a cradle-to-clinical pathway. Our CHO and HEK pools routinely surpass 4 g L⁻¹ in 14-day fed-batch, and Fc-variant libraries (IgG1, IgG4, Xtend) allow rapid PK tuning. Downstream, we pair Protein A/G capture with heterodimer-selective mixed-mode polish to achieve <1 % mis-paired species. Dual-potency analytics—SPR/BLI plus cell-based cytotoxicity—are built into every CQA matrix. Antibody Fragments & Nanobodies — Single-domain VHHs, diabodies, minibodies, scFv-fusions—our fragment platform leverages microbial or mammalian hosts depending on folding complexity. Phage/yeast display libraries jump-start affinity maturation, while periplasmic expression and refolding workflows maximize solubility. Typical deliverables include 95 % monomeric purity, endotoxin <0.1 EU mg⁻¹, and kilogram-scale GMP supply for inhaled, topical, or systemic routes. Humanization, developability profiling, and viscosity modeling come standard.
Cytokines & Growth Factors
Engineered cytokines and regenerative growth factors expressed at >10 g L⁻¹, refolded and purified for high potency and ultra-low endotoxin.
Cell & Gene Therapy Services
Our CGT division integrates GMP viral-vector suites (AAV, LVV up to 200 L), closed-system CAR-T/NK manufacturing, and validated LN₂ cryologistics. Suspension HEK293 and Sf9/baculovirus platforms yield >1 × 10¹⁶ vg per batch with empty/full separation via CsCl or affinity columns. For cell therapies, our CliniMACS-Prodigy and G-Rex workflows support autologous 7-day rapid manufacturing or allogeneic master-cell-bank campaigns. Complete CMC, viral-safety, and chain-of-identity documentation readies your program for FDA and EMA submission.
Phage Therapeutics
End-to-end bacteriophage development, from host-range screening and lysogeny control to GMP fermentation, purification, and aseptic fill-finish. QC includes potency, genome stability, and endotoxin <0.1 EU mg⁻¹, with global regulatory dossier support.
Phage-Derived Enzymes
High-yield microbial expression of recombinant lysins, depolymerases, and tailspike proteins in E. coli or Pichia, with advanced refolding, polishing, and stability workflows. ISO 13485- and GMP-grade enzymes delivered for human, veterinary, or diagnostic use.
Oncolytic Viral CDMO Services
At Elise Biopharma, we provide comprehensive CDMO services for oncolytic viruses (OVs)—a rapidly expanding class of cancer therapeutics. Oncolytic viruses selectively infect and lyse tumor cells while stimulating systemic anti-tumor immunity, and they represent one of the most promising frontiers in immuno-oncology. We support development across major viral backbones, including vaccinia, herpes simplex virus (HSV), adenovirus, measles virus, and engineered novel platforms. Our infrastructure is designed to meet the technical and regulatory challenges of OV manufacturing: consistent amplification, genetic stability, tumor-selective potency, and compliance with oncology’s most demanding frameworks. Capabilities include cell line engineering, upstream amplification in single-use bioreactors, downstream purification via TFF and chromatography, and robust QC covering genetic stability, potency, infectivity, and safety. We also provide formulation and aseptic fill-finish, with cryopreservation and LN₂ logistics to support global trial deployment. Elise Biopharma offers seamless scale-up from 2 L to 2,000 L GMP manufacturing, validated scale-down models, and Stage 3 process validation to ensure clinical and commercial readiness. Our regulatory team supports IND, CTA, and BLA submissions across FDA, EMA, PMDA, and global agencies. Whether you are building a next-generation vaccinia armed with cytokines or a novel engineered adenovirus, Elise Biopharma provides the speed, rigor, and global readiness to accelerate your OV program into the clinic.
Exosome CDMO Services
At Elise Biopharma, we deliver CDMO services for exosomes and extracellular vesicles (EVs)—an emerging modality transforming drug delivery, regenerative medicine, and oncology. Exosomes are natural nanocarriers secreted by cells, able to cross biological barriers, deliver RNA and protein payloads, and modulate immune responses. Their potential is vast, but so are the manufacturing and regulatory challenges. Our services span discovery to GMP supply, including upstream exosome production from MSCs, iPSCs, HEK293, CHO, or custom-engineered producer lines, all adapted to serum-free conditions. We support bioreactor-based production from 2 L to 2,000 L, ensuring scalability and reproducibility. Purification workflows include tangential-flow filtration, chromatography, and immunoaffinity capture, with proprietary polishing steps to remove protein aggregates, nucleic acids, and host contaminants. Our QC suite provides particle sizing (NTA, DLS), electron microscopy, surface marker profiling (CD63, CD81, CD9), RNA/protein cargo analysis, potency assays, and full sterility/endotoxin testing. Formulation options include liquid, lyophilized, and payload-loaded exosomes, with aseptic fill-finish into vials, syringes, or cartridges. We also offer regulatory dossier support, helping clients navigate evolving exosome frameworks across FDA, EMA, and PMDA. Elise Biopharma stands out with its integrated process development, GMP production, QC, and regulatory guidance, providing innovators with the infrastructure to accelerate exosome programs into clinical and commercial success.
Bacteriocin CDMO Services
Bacteriocins are a diverse class of ribosomally synthesized antimicrobial peptides with growing applications in human therapeutics, microbiome modulation, veterinary medicine, and food safety. Unlike broad-spectrum antibiotics, bacteriocins are narrow-spectrum, highly potent, and often species-specific — making them valuable tools in the fight against antimicrobial resistance (AMR) and as precision microbiome modulators. At Elise Biopharma, we provide end-to-end bacteriocin CDMO services: strain engineering and pathway refactoring, high-density microbial fermentation, advanced downstream purification, and regulatory-grade QC. We support multiple bacteriocin classes, including lantibiotics, colicins, microcins, and engineered hybrids, with applications ranging from injectable anti-infectives to GRAS-certified food preservatives. Our GMP infrastructure covers formulation, aseptic fill-finish, and lyophilization, with full regulatory support for therapeutic, veterinary, and food use cases. Whether you’re developing a novel lantibiotic or scaling an engineered bacteriocin platform, Elise delivers precision, scalability, and regulatory readiness.
Fungal Biologics
Development and scale-up of Trichoderma, Aspergillus, and other filamentous fungi for recombinant proteins, specialty enzymes, and secondary metabolites. Expertise includes strain engineering, high-density fermentation, and non-Newtonian DSP, with full QC of glycoforms, potency, and stability. GMP production and regulatory dossier support enable human, food, and industrial applications.
Probiotics and Synbiotics
Elise Biopharma delivers end-to-end CDMO solutions for engineered probiotics and synbiotics—from strain design to GMP release and global distribution.
Cell-Free Biomanufacturing
Elise Biopharma provides end-to-end CDMO services for cell-free systems (TX-TL, ribosome extracts, PURE platforms), enabling rapid DNA-to-protein prototyping without host-cell constraints. Capabilities include microbial and mammalian extract preparation, fed-batch energy regeneration, and lyophilized kit formats for distributed use. Full GMP scale-up (1 L–2,000 L), regulatory dossier support, and integrated QC/QA ensure cell-free solutions are deployable across therapeutics, diagnostics, food-tech, and defense applications.
Nutraceutical Probiotic CDMO Services
At Elise Biopharma, we help nutraceutical brands turn GRAS probiotic strains like Lactobacillus plantarum and Bacillus coagulans into safe, stable products consumers can trust. From fermentation and purification to drying and encapsulation, we make sure probiotics stay alive and effective from factory to shelf. Our team also develops blends, synbiotics, and formats like capsules, stick packs, drinks, and powders. With quality testing, regulatory support, and GMP-aligned production, Elise delivers end-to-end probiotic CDMO services—helping you scale innovation into real consumer health products.
ADC & Bioconjugate CDMO Services
Elise Biopharma turns unforgiving chemistry into clean filings with a true end-to-end platform. We supply/express the binder (CHO/HEK/VHH), synthesize and qualify linker–payloads (MMAE/MMAF, DM1/DM4, PBDs, duocarmycins, topoisomerase inhibitors, novel modalities), then run site-specific or stochastic conjugation (Sortase A, TGase, aldehyde-tag/oxime, UAA, glycan remodeling, re-bridging, maleimide) inside OEB-5 barrier isolators. Polishing and formulation tame hydrophobicity (PEG/spacers; liquid or lyo DP), and phase-appropriate release plus global dossier support carry you from IND to PPQ to commercial. Speed stays audit-ready: QbD, PAT, and digital-twin controls compress timelines while eBR/MES locks data integrity. Orthogonal analytics—HIC/native-MS DAR, peptide-mapping site localization, free drug/linker by UPLC-MS, SEC-MALS/CE-SDS, stability—de-risk comparability and approvals. Beyond classic cytotoxic ADCs, we build AOCs, protein/peptide conjugates, PEGylated polymers, and radioconjugate cold chemistry. One partner, all modalities—fewer surprises, more wins.
LNP & Advanced Nanoparticles
Elise Biopharma designs and manufactures lipid nanoparticles, liposomes, solid-lipid/nanostructured carriers, lipid–polymer hybrids, dendrimers, and micelles for mRNA/saRNA/circRNA, siRNA/ASO, pDNA, CRISPR RNPs, proteins/peptides, and small molecules. We pair rational excipient selection (ionizable lipids by pKa/linker/tail architecture; DSPC/DOPE; cholesterol; PEG-lipid anchor/chain length) with closed, single-use microfluidic mixing that preserves FRR/TFR, solvent fraction, and temperature across scales. Orthogonal analytics—size/PDI and morphology, encapsulation, zeta potential, residual solvents, lipid composition, potency, sterility/endotoxin, and subvisible particles—tie CQAs to CPPs from development through GMP manufacturing, sterile fill–finish, and global logistics. Every program runs on a defined design space (DoE + PAT) so tech transfer reads like a control strategy, not lab notes. We tailor particles and presentations to route (IM/IV/SC/inhaled/ophthalmic/intratumoral), qualify frozen or refrigerated storage with clear freeze–thaw limits, and develop lyophilized formats that reconstitute without size creep or potency loss. Digital twins connect mixing levers to size, PDI, and encapsulation for defensible setpoints, while eBR/MES ensures data integrity—delivering fast, predictable, audit-ready scale-up and CMC answers that hold up in review.
saRNA and circRNA Manufacturing
Elise Biopharma manufactures self-amplifying RNA (saRNA) and circular RNA (circRNA) end-to-end—template architecture, long-run IVT, high-efficiency circularization or replicon assembly, LNP encapsulation tuned to length/topology, sterile fill–finish, and GMP release. We engineer templates for translation and stability (UTRs/IRES/replicase cassettes), control fidelity and dsRNA during IVT with context-appropriate capping/tailing (saRNA) or cap-/poly(A)-free designs (circRNA), and validate circularity and integrity with orthogonal QC: RNase R challenge, long-read/nanopore mapping, advanced electrophoresis, residual DNA/enzymes, dsRNA assays, potency, sterility/endotoxin, and stability—packaged with phase-appropriate specs and dossier support. Scale-up is de-risked by a defined design space (DoE + PAT) and digital twins that link enzyme kinetics, impurity formation, and mixing to CQAs, then lock defensible setpoints for supplier/site/scale changes. Closed, single-use operations, eBR/MES data integrity, and comparability plans make tech transfer routine, while route-matched LNPs and qualified storage (frozen/refrigerated; lyophilized when required) keep timelines fast, predictable, and audit-ready from sequence to clinic.
Radiopharmaceutical Services (Lu-177 / Ac-225)
Elise Biopharma is the radioligand & radioimmunoconjugate CDMO teams call when isotope supply is non-negotiable and the clock is ticking. We lock in Lu-177 (no-carrier-added and carrier-added) and Ac-225 through allocations/MOUs, run Annex 3–aligned hot labs with shielded isolators and manipulators, and keep everything under one roof—binder supply, chelator/linker chemistry, site-specific conjugation, hot labeling, purification, sterile DP formulation, QP release, and global delivery. One partner, one schedule, no drama. We make speed audit-ready: ALARA-by-design facilities, decay-aware GMP scheduling, and orthogonal QC (radiochemical purity by radio-HPLC/iTLC; radionuclidic purity by gamma spectrometry; molar activity; residual metals by ICP-MS; sterility/endotoxin). Digital twins and PAT compress development; eBR/MES preserves data integrity; theranostic pairing and dosimetry-ready releases mean clinics can dose on time. If you’re searching for best-in-class Lu-177 or Ac-225 CDMO support, this is the standard to beat.
In Vitro Microbiology CDMO Services — Explore Elise Biopharma’s in vitro microbiology CDMO services: precision fermentation, AI-driven analytics, GMP-aligned data, and functional assays for probiotics, enzymes, and microbial therapeutics transforming biology into validated, manufacturable innovation.
Ready to explore a modality in depth?
Ready to go deeper? Each section above links to a dedicated page with design blueprints, analytical panels, scale-up curves, and phase-appropriate regulatory paths. If your molecule straddles platforms—or you’re weighing trade-offs—our scientific engagement team will run a rapid “route-to-GMP” mapping session: clarify target product profile, rank hosts by technical and economic fit, outline critical experiments, and sketch a tech-transfer plan with timelines and risks.
You’ll leave with a defensible path from sequence to sterile vial, clear decision gates, and an integrated CMC plan that survives both audit and reality. When complexity refuses to sit still, we make the path coherent.
Contact our team today at info@elisebiopharma.com